Table 5.

Monoclonal antibody infusion therapy and process recommendations for the COVID-19 pandemic and future emerging public health threats

Monoclonal antibody recommendation	Description
Incorporate monoclonal antibodies into pandemic preparedness and response and existing health systems as an early intervention	Monoclonal antibodies can:
	Be manufactured rapidly after neutralizing antibody identification
	Provide immediate immunologic support when other medical counter measures (MCMs) are under development or require time to achieve full effectiveness such as vaccines
	Serve as prophylaxis for individuals at high risk for infection
	Adapt to many forms of deployment during a public health emergency
	Integrate into existing health system processes such as existing outpatient infusion processes and ED/Urgent Care med visits
Strengthen process workflow and environment flexibility during public health emergency	Adjust monoclonal antibody administration process to policy changes
	Critical to monitor and evaluate process workflow to optimize and remain flexible to public health emergency conditions
	Adapt monoclonal antibody administration environment to infection control, weather, drug, and staffing changes
Adapt staffing models to minimize burden, and maximize targeted skills	Establish workflow with minimal staffing needs
	Balance staffing needs with other emergency response activities
	Integrate non-traditional health care workers such as medical volunteers and paramedics
Infusion site location expansion and innovative administration	Community-based sites: multiple medical centers partner to implement a monoclonal antibody infusion site, share resources and staffing, and minimize individual burden
	Rapid testing adjacent sites: co-locate monoclonal antibody site with rapid testing capabilities to refer and immediately treat patients
	Car-based infusion or injection: alleviate the physical environment by delivering monoclonal antibodies and observing patients in cars
	Home administration: administer monoclonal antibodies in patients’ homes
	Nursing homes: administer monoclonal antibodies in nursing homes or long-term care facilities
Ensure strong engagement and equity	Engage with local communities to dispel misinformation and disinformation regarding treatments
	Empower communities and providers with the knowledge of new therapeutic options and impact data
	Ensure monoclonal antibody allocation equity by directing information to populations that are vulnerable, most in need, and likely to meet eligibility criteria
Improved therapy formulations and delivery mechanisms	Expand and improve routes of drug administration for therapies, especially rapid methods such as subcutaneous, intramuscular, and microneedle transdermal administration
	Strengthen temperature stability and minimize drug product preparation requirements
Standard data collection and effectiveness study integration for outpatients	Establish data collection standards for early adopters of monoclonal antibody infusion to permit rapid assessment and large-scale evaluation
	Pair monoclonal antibody distribution with data collection network to better understand the therapeutic impact during EUA periods
Sustainable use and public health integration through other disease targets	Promote monoclonal antibodies in emerging infectious disease preparedness and response toolkit
	Build upon the therapeutics momentum from the pandemic
	Continue innovative monoclonal antibody research and study delivery mechanisms and emergency implementation techniques
	Partner with organizations researching the application of monoclonal antibodies for other disease targets and public health threats